Isofol Medical AB (publ) announced that analysis of the AGENT study's final data confirmed topline results presented on August 3, 2022. Moreover, no predictive gene expressions for clinical response could be identified. The company is continuing its efforts to terminate the AGENT study in line with applicable ethical and regulatory requirements, complete the final study report for submission to regulatory agencies and prepare a manuscript for a scientific publication.

The company is in parallel continuing to investigate possible future paths forward for the company. On August 3, 2022, the company presented topline results showing that the AGENT study met neither its primary endpoint nor key secondary endpoint. Based on analysis of additional study data that Isofol obtained since then, the company can confirm that the AGENT study's final data confirms the conclusions that were communicated in conjunction with topline results and study updates from August 31 and September 7, namely that: Neither the primary endpoint of objective response rate (ORR) nor the key secondary endpoint of progression-free survival (PFS) were met; With regards to safety data, there were no differences between the study arms with the exception of a non-statistically significant detriment in overall survival (OS) in the arfolitixorin arm; There were no significant differences in any major subgroups; There were preliminary indications that the risk of death was 11 percent greater in the experimental arm compared with the control arm.

Data surrounding gene expression was also analyzed during the fourth quarter. Conclusions from this analysis did not identify any predictive biomarkers. The company's work to terminate the AGENT study, which currently involves detailed quality control and regulatory documentation from the study sites involved, is continuing, and is estimated to be completed by the turn of the year.

The company intends to publish key data from the study in a scientific publication to enable the medical community to fully leverage the lessons learned from the study. The preparation of a manuscript for scientific publication is ongoing and the intention is to submit it to a peer-reviewed journal in oncology during the first quarter of 2023.